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| Thử nghiệm lâm sàng ngẫu nhiên có đối chứng tiến cứu× | Giai đoạn III Thử nghiệm lâm sàng× | |
|---|---|---|
| Lĩnh vực | Dịch tễ học | Dịch tễ học |
| Họ | Process / pipeline | Process / pipeline |
| Năm ra đời≠ | 1948 (landmark MRC streptomycin trial) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| Người khởi xướng≠ | Austin Bradford Hill / Medical Research Council | FDA regulatory framework / ICH guidelines |
| Loại≠ | Experimental / interventional study design | Confirmatory randomised controlled trial |
| Công trình gốc≠ | Medical Research Council (1948). Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation. British Medical Journal, 2(4582), 769–782. link ↗ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385 |
| Tên gọi khác | Prospective RCT, randomized controlled trial, RCT, controlled clinical trial | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| Liên quan≠ | 5 | 6 |
| Tóm tắt≠ | A prospective randomized clinical trial (RCT) is an experimental study in which participants are assigned to intervention or control groups by chance before any outcomes are observed, then followed forward in time. Random allocation eliminates systematic selection bias, making this design the gold standard for establishing causal efficacy of treatments in medicine and clinical research. | A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption. |
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